FDA-Designed Studies Reveal Risk of Invokana Amputations

While the FDA previously received an influx of reports from patients who experienced serious side effects related to the use of Invokana, it wasn’t until two FDA-designed studies were completed that the increased risk of amputations came to light.

The CANVAS and CANVAS-R were actually designed to measure the risk of cardiovascular and renal (kidney) issues associated with the use of Invokana when compared to a placebo. CANVAS was a year-long study that tracked 1,000 patients. That initial study showed that 5.9 patients out of the 1,000 had a higher risk of leg amputation. Only 2.8 people treated with the placebo faced that increased risk.

CANVAS-R also lasted a year and included 1,000 patients. This study, designed to measure renal problems associated with Invokana, showed that 7.5 patients taking the drug had an increased risk amputation. Only 4.2 of the patients taking the placebo had the same risk.

Invokana Still on the Market Despite Amputation Risk

Despite a black box warning required by the FDA, Invokana remains on the market. The purpose of the black box warning is to inform patients of the increased risk of amputation. Yet, it’s important to remember that many patients don’t read the information that comes with their prescriptions.

Invokana Amputation Lawsuits Moving Forward in Court

Unfortunately, patients using Invokana to control their Type II Diabetes face a higher risk of toe, foot, and leg amputations. In fact, several Invokana amputation lawsuits have been filed and are moving forward in court.

The most common Invokana amputations include the toe and foot. However, some patients needed a leg amputation. Sadly, some patients required more than one amputation. In October 2017, a Texas man filed an Invokana amputation lawsuit claiming that he developed a diabetic ulcer on his leg that ultimately resulted in the need for an amputation. The most surprising part of his lawsuit is the short amount of time the plaintiff took Invokana before facing such a serious problem: just five months.

In November 2017, Invokana lawsuits were consolidated through a process known as multi-district litigation. This helps speed up some of the discovery and administrative functions in the case, but each case is still heard on its merit. That means each plaintiff who wins or the case their case settles in their favor, the amount determined is for their case. It is not split between all of the plaintiffs like it would be if it were a class action lawsuit.